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FDA STATEMENT

FOR IMMEDIATE RELEASEJune 30, 2004

Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA

FDA is Alerting the Public to Counterfeit Viagra Found in Two California Pharmacies

FDA is alerting pharmacies and the public of a small number of confirmed reports involving counterfeit Viagra (sildenafil citrate) sold in two California pharmacies. Both FDA and Pfizer, Inc. of Groton, CT, the manufacturer of the legitimate drug Viagra, are analyzing the counterfeit product to determine its true composition and whether it poses any health risks.

To date no injuries have been reported in connection with this problem and the counterfeit products have only been found in pharmacies in Glendale and Fresno, California.

It is important to note that the concern over these counterfeit drugs in no way applies to real Viagra tablets which are formulated and manufactured in strict compliance with FDA’s standards.

Pfizer and FDA are providing pharmacists and the public with information on how to identify counterfeit Viagra packaging and tablets. The counterfeit drugs bear the lot number 3023803 with an expiration date of 1 MAR 06 (this lot number and date were used on legitimate Viagra product distributed between July 1 and July 18, 2003) and resemble real Viagra tablets in terms of their general size, shape, color and debossing (imprints). Yet several significant deviations are evident between the counterfeit and real drugs - these differences can be seen in comparative photos included with Pfizer’s Dear Pharmacist letter, posted on the company’s Website at http://www.pfizer.com/subsites/counterfeit_importation/mn_pharmacist_viagra.html. These differences include a different debossing font, more pronounced tablet edges, and the lighter blue film-coat.

Consumers who have Viagra at home and may have questions about its legitimacy can reference the above websites or contact the dispensing pharmacist. Pharmacists and consumers who have counterfeit Viagra should contact their local FDA office.

FDA’s Office of Criminal Investigations is actively investigating this case and the agency will aggressively prosecute those found responsible for any counterfeiting operation.